Treatment of thrombosed hemodialysis access grafts: Arrow-Trerotola percutaneous thrombolytic device versus pulse-spray thrombolysis. Arrow-Trerotola Percutaneous Thrombolytic Device Clinical Trial.
OBJECTIVE
To evaluate a percutaneous thrombolytic device (PTD) designed for treating thrombosed hemodialysis access grafts.


METHODS
To compare the PTD with pulse-spray pharmacomechanical thrombolysis (PSPMT) by using urokinase, 122 randomly chosen patients with synthetic, thrombosed hemodialysis access grafts from multiple centers prospectively underwent thrombolysis with the PTD (5-F, low-speed rotational mechanical device) or PSPMT. Major outcome variables included the procedure time, the immediate technical patency rate, the complication rate, and the 3-month patency rate.


RESULTS
Sixty-four PTD and 58 PSPMT procedures were performed with intent to treat. The immediate technical patency rate was 95% (61 of 64 [PTD] and 55 of 58 [PSPMT]) in both procedures. Median procedure times were 75 minutes in the PTD group (range, 25-209 minutes) and 85 minutes in the PSPMT group (range, 50-273 minutes; P < .04). Major complications occurred in 8% (five of 64) of PTD procedures (none related to the PTD) and 9% (five of 58) PSPMT procedures (not significant). Two devices broke (one during training) with no clinical sequela. The 3-month primary patency rate was 39% (25 of 64) in the PTD group and 40% (23 of 58) in the PSPMT group (not significant).


CONCLUSIONS
The PTD is safe and effective for treating thrombosed hemodialysis access grafts. The technical and long-term success rates are similar to those of PSPMT; procedure times are shorter.
Trerotola
S O
SO
Department of Radiology, Indiana University School of Medicine, Indianapolis 46202-5253, USA.
Vesely
T M
TM
Lund
G B
GB
Soulen
M C
MC
Ehrman
K O
KO
Cardella
J F
JF
D016292:Procedural Sedation; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010960:Plasminogen Activators / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011446:Prospective Studies; D006435:Renal Dialysis; D017131:Thrombectomy / Q000009:adverse effects / Q000295:instrumentation*; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods*; D013927:Thrombosis / Q000628:therapy*; D013997:Time Factors; D014568:Urokinase-Type Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D014654:Vascular Patency
D010960:Plasminogen Activators; D014568:Urokinase-Type Plasminogen Activator